Regulatory T-cell therapy

Class

Autologous/expanded regulatory T-cell (Treg) cellular therapy

Regulatory T cells, or Tregs, are a subset of CD4-positive white blood cells that normally act as a brake on the immune system, preventing it from attacking the body's own tissues and dampening excessive inflammation once a threat has been cleared. They are defined by expression of the transcription factor FOXP3, which programs their suppressive function. In autoimmune disease, organ transplantation, and graft-versus-host disease, natural Treg numbers or function can be insufficient to control harmful immune activity, allowing conventional immune cells to damage healthy tissue or transplanted organs. Treg cell therapy involves isolating a patient's own Tregs (or donor-derived cells), expanding them in large numbers outside the body, and reinfusing them to restore or reinforce this suppressive capacity. The rationale is to achieve targeted, durable immune tolerance without the broad, indiscriminate immune suppression caused by conventional drugs, which leave patients vulnerable to infection. This approach is being explored across conditions where immune overactivity or graft rejection drives disease, including autoimmune disorders and complications following stem cell or organ transplantation. Because the cells are living and can persist, potentially self-renewing after infusion, the therapy aims for long-lasting effects from a single or limited treatment course, distinguishing it from drugs requiring continuous dosing.